EBUS-TBNA Versus EBUS-TBNB

July 12, 2016 updated by: Royal Brompton & Harefield NHS Foundation Trust

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial

A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).

The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, D-69126
        • Thoraxklinik, University of Heidelberg
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital
      • London, United Kingdom, SW3 6NP
        • The Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for EBUS-TBNA as part of clinical care
  • Lymph nodes larger than 10mm in diameter
  • Age > 18 years
  • Able to provide written informed consent

Exclusion Criteria:

  • Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
  • Inability to obtain informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EBUS-TBNA
Sampling using endobronchial ultrasound guided transbronchial needle aspiration
Device: Endobronchial ultrasound guided lymph node sampling
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Other Names:
  • Olympus EBUS-TBNA needle
  • Olympus EBUS-TBNB biopsy forceps
Experimental: EBUS-TBNB
Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
Device: Endobronchial ultrasound guided lymph node sampling
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Other Names:
  • Olympus EBUS-TBNA needle
  • Olympus EBUS-TBNB biopsy forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
Time Frame: 18 months

The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:

  • Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.
  • Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.
  • Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in the complication rate between the two study arms
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Heidelberg University
Chelsea and Westminster NHS Foundation Trust

Investigators

  • Study Director: Zaid Zoumot, MBBS, MRCP, MSc, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
  • Principal Investigator: Pallav L Shah, MD, FRCP, Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011PA002B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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